Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Priority
Applicant’s claim for the benefit of a prior-filed application (CON of 16/800,454, filed 25 February 2020, now US Patent 11,994,499; which has PRO 62/811,029, filed 27 February 2019) under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
Claims 9-12, 14, 18, 20, 21, 23-25, 29-36, and 38 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding Claim 9, there is insufficient antecedent basis for “the mobile phase” in lines 3-4. Claims 10-12, 14, 18, 20, 21, 23-25, 29-36, and 38 are also rejected due to their dependence on Claim 9.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 9, 33, and 34 are rejected on the ground of nonstatutory double patenting as being unpatentable over Claims 1, 4, and 5 of U.S. Patent No. 11,709,155 B2.
Regarding Claim 9, all recited limitations of Claim 9, i.e., a sample injector having a sample injection needle, a sample reservoir container in fluid communication with the sample injector, a chromatography column downstream of the sample injector, the chromatography column having fluid connectors, fluid conduits connecting the sample injector and the chromatography column, and wherein interior surfaces of the fluid conduits, sample injector, sample reservoir container, and chromatography column form a fluidic flow path having wetted surfaces, are read upon by Claim 1 of US 11,709,155 B2. Furthermore, the recited limitation of “wherein at least a portion of the wetted surfaces of the fluidic flow path are coated with an alkylsilyl coating having the Formula I” is also read upon by Claim 1 of ‘155 where RB and RD are absent and each X is independently selected from a (C1-C6)alkoxy, a -NH(C1-C6)alkyl, a -N((C1-C6)alkyl)2, OH, ORA, RC, and halo.
Regarding Claims 33 and 34, Claim 1 of ‘155 renders unpatentable the chromatographic device of Claim 9. The instantly recited limitations of Claims 33 and 34 are read upon by Claims 4 and 5, respectively, of ‘155. Claim 4 of ‘155 discloses a detector downstream of the column and that the fluidic flow path further comprises the detector as recited by Claim 33 of the instant application; Claim 5 of ‘155 discloses the detector is a mass spectrometer and that the fluidic flow path includes wetted surfaces of an electrospray needle as recited by Claim 34 of the instant application.
Claim 29 is rejected on the ground of nonstatutory double patenting as being unpatentable over Claim 1 of U.S. Patent No. 11,709,155 B2 in view of CARR et al. (US 2015/0024152 A1).
Regarding Claim 29, Claim 1 of ‘155 renders unpatentable the chromatographic device of Claim 9. Claim 1 of ‘155 is deficient in disclosing the chromatography column includes a frit having a wetted surface coated with the alkylsilyl coating of Formula I.
CARR discloses internal surfaces (e.g., lumen, passageways, or cavities) of metal components of a chromatography system are coated with a coating to advantageously render the metal components inert (p0003; p0008); such coatings include organosilica compounds such as polymeric siloxanes (p0035, p0044, p0045). These internal surfaces include frits (p0034). Thus, prior to the effective filing date of the claimed invention, one of ordinary skill in the art would have found it obvious that all internal surfaces, including frits, of a chromatography column be coated with an organosilica coating to advantageously render inert as taught by CARR for the chromatographic device taught by ‘155.
Claims 31 and 32 to Claim 1 of US 11,709,155 in view of CARR and further in view of SHALLIKER et al. (US 20130306558 A1).
Regarding Claims 31 and 32, modified Claim 1 of ‘155 renders unpatentable the chromatographic device of Claim 29. Modified Claim 1 of ‘155 is deficient in disclosing the frit is positioned at an outlet of the chromatography column (Claim 31) or at the inlet of the chromatography column (Claim 32).
However, frits are commonly located at the outlet and inlet positions of chromatography columns As indicated by SHALLIKER, inlet and outlet frit assemblies are located at the inlet and outlet ends of a chromatography column (p0095, p0065). Absent showings of criticality or non-obviousness, the positioning of frits whether at the outlet or inlet of the chromatography column would be obvious to one of ordinary skill in the art prior to the effective filing date of the invention. The location of a frit or multiple frits would not impact the claimed chromatographic device with any significance, i.e., a sample comprising analytes will be introduced into a chromatographic system whether a frit was located at the inlet or outlet of the chromatographic column. All claimed elements were known in the prior art and one of ordinary skill in the art could have combined the elements as claimed by known methods with no change in their respective, individual functions, and the combination would have yielded nothing more than predictable results (MPEP §2143.01 A).
Claims 9, 33, and 34 are rejected on the ground of nonstatutory double patenting as being unpatentable over Claims 1, 6, and 7 of U.S. Patent No. 12,416,607 B2.
Regarding Claim 9, all recited limitations of Claim 9, i.e., a sample injector having a sample injection needle, a sample reservoir container in fluid communication with the sample injector, a chromatography column downstream of the sample injector, the chromatography column having fluid connectors, fluid conduits connecting the sample injector and the chromatography column, and wherein interior surfaces of the fluid conduits, sample injector, sample reservoir container, and chromatography column form a fluidic flow path having wetted surfaces, are read upon by Claim 1 of US 12,416,607 B2. Furthermore, the recited limitation of “wherein at least a portion of the wetted surfaces of the fluidic flow path are coated with an alkylsilyl coating having the Formula I” is also read upon by Claim 1 of ‘607 by the recitation of “a bioinert coating… [of] bis(trichlorosilyl)ethane or bis(trismethoxysilyl)ethane”.
Regarding Claims 33 and 34, Claim 1 of ‘607 renders unpatentable the chromatographic device of Claim 9. The instantly recited limitations of Claims 33 and 34 are read upon by Claims 6 and 7, respectively, of ‘607. Claim 6 of ‘607 discloses a detector downstream of the column and that the fluidic flow path further comprises the detector as recited by Claim 33 of the instant application; Claim 7 of ‘607 discloses the detector is a mass spectrometer and that the fluidic flow path includes wetted surfaces of an electrospray needle as recited by Claim 34 of the instant application.
Claim 29 is rejected on the ground of nonstatutory double patenting as being unpatentable over Claim 1 of U.S. Patent No. 12,416,607 B2 in view of CARR et al. (US 2015/0024152 A1).
Regarding Claim 29, Claim 1 of ‘607 renders unpatentable the chromatographic device of Claim 9. Claim 1 of ‘607 is deficient in disclosing the chromatography column includes a frit having a wetted surface coated with the alkylsilyl coating of Formula I.
CARR discloses internal surfaces (e.g., lumen, passageways, or cavities) of metal components of a chromatography system are coated with a coating to advantageously render the metal components inert (p0003; p0008); such coatings include organosilica compounds such as polymeric siloxanes (p0035, p0044, p0045). These internal surfaces include frits (p0034). Thus, prior to the effective filing date of the claimed invention, one of ordinary skill in the art would have found it obvious that all internal surfaces, including frits, of a chromatography column be coated with an organosilica coating to advantageously render inert as taught by CARR for the chromatographic device taught by ‘607.
Claims 31 and 32 to Claim 1 of US 12,416,607 in view of CARR and further in view of SHALLIKER et al. (US 20130306558 A1).
Regarding Claims 31 and 32, modified Claim 1 of ‘607 renders unpatentable the chromatographic device of Claim 29. Modified Claim 1 of ‘607 is deficient in disclosing the frit is positioned at an outlet of the chromatography column (Claim 31) or at the inlet of the chromatography column (Claim 32).
However, frits are commonly located at the outlet and inlet positions of chromatography columns As indicated by SHALLIKER, inlet and outlet frit assemblies are located at the inlet and outlet ends of a chromatography column (p0095, p0065). Absent showings of criticality or non-obviousness, the positioning of frits whether at the outlet or inlet of the chromatography column would be obvious to one of ordinary skill in the art prior to the effective filing date of the invention. The location of a frit or multiple frits would not impact the claimed chromatographic device with any significance, i.e., a sample comprising analytes will be introduced into a chromatographic system whether a frit was located at the inlet or outlet of the chromatographic column. All claimed elements were known in the prior art and one of ordinary skill in the art could have combined the elements as claimed by known methods with no change in their respective, individual functions, and the combination would have yielded nothing more than predictable results (MPEP §2143.01 A).
Allowable Subject Matter
Claims 10-12, 14, 18, 20, 21, 23-25, 30, 35, 36, and 38 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
The claimed invention is directed to a chromatographic device having inner surfaces in contact with a sample (e.g., internal lumens) coated with an active coating comprising a specific alkylsilyl coating of Formula I. A search of the prior art reveals that such an alkylsilyl coating of Formula I of Claim 9 is known in the art, as shown by NAKAJIMA et al. (US 2009/0206034 A1); however, NAKAJIMA discloses the use of such a polymeric siloxane as a coating for a chromatographic support (e.g., resin/matrix) and not as a coating for the inner surfaces defining the fluidic flow path of a chromatographic device. Even further, dependent Claims 10-12, 14, 18, 20, 21, 23-25, 30, 35, 36, and 38 recite further limitations defining the RA, RB, RC, and RD groups of Formula I that are not disclosed by or obvious over NAKAJIMA or any other recited prior art.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RYAN B HUANG whose telephone number is (571)270-0327. The examiner can normally be reached 9 am-5 pm EST.
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/Ryan B Huang/Primary Examiner, Art Unit 1777
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